Senior Compliance Engineer in Southam

Astor Bannermans Medical Device product line is continually evolving and growing. We require an experienced compliance engineer to help us navigate our regulatory requirements for new and existing products. If you want to be part of a company creating products that directly improve people's lives, then this is a perfect opportunity.

Requirements:

• You’ll be a technically capable and detail-oriented engineer with experience in medical device testing and certification, with a strong grasp of compliance standards.
• A relevant degree i.e. Engineering (Elec eng. preferred), Medicine or another relevant scientific discipline or 6 years experience in a compliance or regulatory affairs role.
• Hands-on experience in product testing and validation.
• Knowledge of regulatory requirements for Class I medical devices to MDD and MDR.
• Experience and competence complying to ISO9001, ISO13485, ISO14971.
• Experience testing and complying to IEC60601-1 and other parts (such as -2, -6, -11).
• Strong analytical and documentation skills.
• Proactive, organised, self-starter & passionate about standards.
• Confident communicator, able to work across functions and to external agencies.

Responsibilities:

• Technical Content File creation, maintenance and ownership.
• Support product classification levels of medical & machine products.
• Plan, conduct and oversee all testing both internally and externally.
• Operate and maintain any testing equipment.
• Ensure compliance for the full product range, regularly updating where needed to UK, EU, USA and ROW.
• Support Certification submissions and liaise with regulatory bodies and test houses.
• Collect and analyse test data, providing detailed reports and recommendations.
• Carry out risk assessments and FMEAs to support safe and compliant design.
• Stay up to date on applicable standards and regulations.
• Drive improvements across R&D in test methods, documentation and compliance processes.
• Ensure documentation, drawings, labels, manuals, etc. are accurate and consistent.
• Integrate best practice into the R&D engineering team.

Our Company:

We design, develop and manufacture paediatric medical equipment. Our products are primarily focused on washing, bathing, changing and handling solutions that directly improve people's lives. We have been established for over 30 years but are now heavily investing in our future as we are expanding.

Why should you apply?

• Competitive salary based on experience & flexible hours.
• Working in a small, fun & dynamic R&D and Quality team.
• Surrounded by the beautiful Cotswolds but close to Cheltenham (GL54).
• Immediate start possible, on-site parking.
• Healthcare scheme, bike to work & pension contribution.
• Growing business where you can really make an impact on your career whilst improving other people's wellbeing.